deutarserine (CTP-692) / Sun Pharma - LARVOL DELTA

[VIRTUAL] D-Serine Safety: A Cross Species Review (SOBP 2021) - "Across published studies, D-serine appears safe. Further study of high dose D-serine and CTP-692 is needed to confirm safety over extended periods."

Clinical • Review • CNS Disorders • Cognitive Disorders • Mood Disorders • Psychiatry • Schizophrenia

[VIRTUAL] D-Serine Safety: A Cross Species Review (SOBP 2021) - "Across published studies, D-serine appears safe. Further study of high dose D-serine and CTP-692 is needed to confirm safety over extended periods."

Clinical • Review • CNS Disorders • Cognitive Disorders • Mood Disorders • Psychiatry • Schizophrenia

Concert Pharmaceuticals Reports 2020 Financial Results and Provides Update on Clinical Programs (Businesswire) - "Research and development expenses were $61.6 million for the year ended December 31, 2020, compared to $59.8 million for the year ended December 31, 2019. The increase in R&D expenses in 2020 relates primarily to costs associated with the Company’s CTP-692 Phase 2 clinical trial in schizophrenia."

Commercial • CNS Disorders • Schizophrenia

A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia (clinicaltrials.gov) - P2; N=326; Completed; Sponsor: Concert Pharmaceuticals; Active, not recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Concert Pharmaceuticals Announces Results from CTP-692 Phase 2 Trial in Patients with Schizophrenia (Businesswire) - P2, N=325; NCT04158687; Sponsor: Concert Pharmaceuticals; "Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced that its Phase 2 clinical trial to evaluate CTP-692 as an adjunctive treatment in patients with schizophrenia did not meet the primary endpoint or other secondary endpoints....“Unfortunately, we didn’t see the results we hoped for to support continuation of this program.' stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals."

Discontinued • P2 data • CNS Disorders • Schizophrenia

DD, CNCE among premarket losers (SeekingAlpha) - "Concert Pharmaceuticals (NASDAQ:CNCE) -47% after CTP-692 study in schizophrenia fails to meet primary or secondary endpoint."

P2 data • Stock price • CNS Disorders • Schizophrenia

Product discontinued (Businesswire) - Schizophrenia

Schizophrenia

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update (Businesswire) - "CTP-692 Topline Data Expected First Quarter of 2021. The treatment duration of the CTP-692 Phase 2 trial is 12 weeks. The Company expects to report topline data in the first quarter of 2021 and believes that positive results would support advancement directly into Phase 3 testing....R&D expenses are expected to continue to increase in 2020 as the Company continues its Phase 2 clinical trial of CTP-692..."

Commercial • P2 data • CNS Disorders • Schizophrenia

A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia (clinicaltrials.gov) - P2; N=325; Active, not recruiting; Sponsor: Concert Pharmaceuticals; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

Concert Pharmaceuticals Completes Enrollment in CTP-692 Phase 2 Trial in Patients with Schizophrenia (Businesswire) - "Concert Pharmaceuticals...today announced that it has completed patient enrollment of its Phase 2 clinical trial to evaluate CTP-692 as an adjunctive treatment in patients with schizophrenia. Topline data from the trial are expected in the first quarter of 2021."

Enrollment closed • P2 data • CNS Disorders • Schizophrenia

Concert Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Company Update (Businesswire) - "The Company continues to expect to complete enrollment in the CTP-692 Phase 2 clinical trial by year-end 2020. The primary outcome measure is the change in the Positive and Negative Syndrome Scale (PANSS) total score at 12 weeks compared to baseline. Topline data is expected soon after trial completion."

Enrollment status • CNS Disorders • Schizophrenia

[VIRTUAL] CTP-692, a Novel Deuterium-Modified D-Serine, Produces Higher Brain Exposure in Rats Compared to D-Serine (ASCP 2020) - "In summary, based on these rat studies, CTP-692 is a potential first-in-class adjunctive treatment for schizophrenia that offers the pharmacological advantages of treatment with D-serine but with the potential for lower risk of renal toxicity, higher brain exposures and efficacy at lower doses. Learning Objectives: Deuterium modification can alter the metabolism/toxicology of a compound without affecting the intrinsic pharmacology of the compound Schizophrenia is associated with low levels of D-serine, the most important synaptic co-agonist of the N-methyl-D-aspartate (NMDA) type glutamate receptor in the brain."

Preclinical • CNS Disorders • Schizophrenia

[VIRTUAL] The Pharmacokinetic and Safety Profile of CTP-692 (Deuterated D-Serine) in Healthy Volunteers: Phase 1 Program Results (ASCP 2020) - "2. Pharmacokinetic and Safety Profile of CTP-692 in Healthy Volunteers."

Clinical • P1 data • PK/PD data • CNS Disorders • Schizophrenia

[VIRTUAL] The Pharmacokinetic and Safety Profile of CTP-692 (Deuterated D-Serine) in Healthy Volunteers: Phase 1 Program Results (ASCP 2020) - "Accumulation of CTP-692 was minimal to modest following 7 consecutive days of administration. Based on the results of the Phase 1 studies, once-daily CTP-692 doses of 1, 2, and 4 g are being evaluated in an ongoing double-blind, placebo-controlled Phase 2 study to evaluate the safety and efficacy of CTP-692 as an adjunctive treatment in adult patients with schizophrenia with a novel mechanism of action."

Clinical • P1 data • PK/PD data • CNS Disorders • Schizophrenia

Concert Pharmaceuticals reports first quarter 2020 financial results and provides update on clinical programs (Businesswire) - "CTP-692 Phase 1 Clinical and Nonclinical Findings to be Presented at ASCP Virtual Meeting. The safety assessments in the single- and multiple-ascending dose Phase 1 trials in healthy volunteers showed that CTP-692 was well tolerated over the dose ranges tested, which included the doses being evaluated in Phase 2 testing....The clinical results will be presented during the pipeline presentation and the nonclinical results will be presented during the poster session at The American Society of Clinical Psychopharmacology (ASCP) annual meeting, to be held virtually on May 29-30, 2020....The Company advanced CTP-692 into a Phase 2 dose-ranging trial as an adjunctive treatment in patients with schizophrenia...Enrollment in the Phase 2 trial is expected to be complete by year-end 2020."

Enrollment status • P1 data • Preclinical • CNS Disorders • Schizophrenia

Concert Pharmaceuticals, Inc. (CNCE) Q1 2020 earnings call transcript (The Motley Fool) - "... COVID-19 has affected all the ongoing clinical trials across the country. Our guidance now is that we'll be able to complete enrollment by year-end and -- so our data readout will occur more than likely in 2021....So I think if we're on track to have enrollment completed by the end of the year, I think the first half is a reasonable expectation."

P2 data • CNS Disorders • Schizophrenia

Concert Pharmaceuticals reports 2019 financial results and provides update on clinical programs (Businesswire) - " 'With the recent initiation of the Phase 2 dose-ranging trial of CTP-692 in patients with schizophrenia, we expect to report topline data by year end that may enable us to advance the program directly into pivotal evaluation in 2021.' "

New trial • P2 data

Concert Pharmaceuticals announces pricing of public offering (Businesswire) - "Concert intends to use the net proceeds from the offering, together with its current cash and cash equivalents, to advance the clinical program for CTP-543 into Phase 3 development for alopecia areata, fund the clinical development of CTP-692 through Phase 2 for schizophrenia, and support its pipeline development, working capital needs and other general corporate purposes."

Financing

A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia (clinicaltrials.gov) - P2; N=300; Recruiting; Sponsor: Concert Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Concert Pharmaceuticals initiates CTP-692 phase 2 trial in schizophrenia (Businesswire) - "Concert Pharmaceuticals, Inc....today announced the initiation of a Phase 2 clinical trial evaluating CTP-692 as an adjunctive treatment for schizophrenia....The Phase 2 trial is designed to evaluate the safety and efficacy of three different doses of CTP-692, compared with placebo, in patients with schizophrenia who are stable on an antipsychotic medication. The Company expects to report topline Phase 2 data by year end 2020."

P2 data • Trial status

Concert Pharmaceuticals to host KOL webcast event focused on CTP-692 and schizophrenia (Businesswire) - "Concert Pharmaceuticals...today announced that it will host a conference call and webcast event with a key opinion leader in the field of psychiatry and schizophrenia on Thursday, November 14, 2019. The event will highlight CTP-692, a novel deuterium-modified form of D-serine being developed as an adjunctive treatment for schizophrenia. The Company intends to advance CTP-692 into Phase 2 clinical evaluation in the fourth quarter of 2019."

Live event • New P2 trial

A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: Concert Pharmaceuticals

Clinical • New P2 trial

"Concert Pharmaceuticals to Host KOL Webcast Event Focused on CTP-692 and Schizophrenia https://t.co/LdSN7j2p43" (@NewsFromBW)

Concert Pharmaceuticals to provide overview of clinical pipeline at Cantor Healthcare Conference (Businesswire) - "Concert Pharmaceuticals...today announced that it will be providing an overview of the Company’s clinical pipeline...at the Cantor Healthcare Conference on Thursday, October 3, 2019 at 5:20 p.m. ET in New York, NY....At the Cantor Healthcare Conference, Dr. Tung will highlight recent developments and upcoming milestones for Concert’s two wholly-owned clinical candidates during the presentation."

Clinical

Pharmacokinetic and safety profile CTP-692 (deuterated D-serine) following administration of single and multiple ascending doses in healthy volunteers (ECNP 2019) - "The well-defined PK and safety profile supports the development of CTP-692 as a potential new therapy for the adjunctive treatment of schizophrenia."

Clinical • PK/PD data